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AsthmaPhase 4AIM4:Next StepNCT06572228

Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma

A Phase 4 study testing dupilumab and ICS/LABA in people with Asthma, run by Regeneron Pharmaceuticals at 77 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Read more about this study

Who is it for?
Ages 12 to 80 years
Conditions the study is for
Asthma
What is being tested?
dupilumab and ICS/LABA
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
77 sitesin 6 countries
Study dates
26 Aug 2024to 24 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
  • Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
  • Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
  • Pre-bronchodilator FEV1, as defined in the protocol
  • Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol
  • Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
Show all 9Show fewer
  • ACQ-5 score ≥1.5 at screening (visit 1)
  • History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
  • Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (~90% of population), as defined in the protocol

Who cannot join

  • Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
  • Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography (CT), magnetic resonance imaging [MRI]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)
  • A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol
  • Weight is less than 30 kilograms
  • Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
  • Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study, as defined in the protocol
  • Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period
  • NOTE: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

77 sites in 6 countries.

77 sites in 6 countries

United States51 sites
  • Michigan Medicine

    Ann Arbor, Michigan, 48109

  • Kern Research, Inc

    Bakersfield, California, 93301

  • Paul A. Shapero, M.D.

    Bangor, Maine, 04401

  • The Asthma and Allergy Center

    Bellevue, Nebraska, 68123

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cincinnati Childrens Hospital and Medical Center

    Cincinnati, Ohio, 45229

  • St Francis Medical Institute

    Clearwater, Florida, 33765

  • Certified Research Associates

    Cortland, New York, 13045

  • Dharma MD PA d/b/a Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas, 75020

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801

  • Western Sky Medical Research

    El Paso, Texas, 79912

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • New York Medical College

    Hawthorne, New York, 10532

  • Henderson Clinical Trials

    Henderson, Nevada, 89052

  • Baylor College of Medicine - Section of Pulmonary and Critical Care

    Houston, Texas, 77030

  • Texas Children's Hospital

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

    Kissimmee, Florida, 34746

  • Modena Allergy & Asthma, Inc.

    La Jolla, California, 92037

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • Bluegrass Allergy Research

    Lexington, Kentucky, 40509

  • Ark Clinical Research, LLC

    Long Beach, California, 90815

  • Family Allergy and Asthma Research Institute

    Louisville, Kentucky, 40217

  • Metroplex Pulmonary and Sleep Center, PA

    McKinney, Texas, 75069

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Montana Medical Research

    Missoula, Montana, 59808

  • Intermountain Medical Center - Murray (Pulmonary Medicine)

    Murray, Utah, 84107

  • Northwell Health at ENT & Allergy Associates

    New York, New York, 10016

  • Newport Native Md, Inc.

    Newport Beach, California, 92663

  • Sneeze Wheeze and Itch Associates

    Normal, Illinois, 61761

  • Lung Sleep Research Institute

    North Richland Hills, Texas, 76180

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Childrens Hospital of Orange County Main Campus

    Orange, California, 92868

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301

  • University of Pittsburgh Asthma and Environmental Health Lung Institute

    Pittsburgh, Pennsylvania, 15213

  • Asthma and Allergy Center of Chicago

    River Forest, Illinois, 60305

  • Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology

    Rochester, New York, 14607

  • South Texas Allergy & Asthma Medical Professionals (STAAMP) Research

    San Antonio, Texas, 78229

  • Raffi Tachdjian MD, Inc.

    Santa Monica, California, 90404

  • Endeavor Health, Skokie Campus

    Skokie, Illinois, 60077

  • Washington University School of Medicine

    St Louis, Missouri, 63119

  • Bensch Clinical Research

    Stockton, California, 95207

  • Integrated Research of Inland, Inc.

    Upland, California, 91786

  • Allergy & Asthma Care of Waco

    Waco, Texas, 76712

  • Allianz Research Institute

    Westminster, California, 92683

  • Clinical Site Partners, LLC DBA Flourish Research

    Winter Park, Florida, 32789

  • Pulmonology Associates Inc.

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Poland9 sites
  • Centrum Medycyny Oddechowej Mroz SJ

    Bialystok, Podlaskie Voivodeship, 15-044

  • Allergy Clinic NZOZ Homeo Medicus

    Bialystok, Podlaskie Voivodeship, 15-687

  • Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny Nieinwazyjnej

    Gdansk, Pomeranian Voivodeship, 80-214

  • Centrum Medyczne All-Med

    Krakow, Lesser Poland Voivodeship, 30-033

  • Diamond Clinic sp zoo

    Krakow, Malopolska, 31-559

  • European Trial Group (ETG) Warsaw

    Warsaw, Mazovian, 02-677

  • Michał Bogacki - DOBROSTAN

    Wroclaw, Lower Silesian Voivodeship, 53301

  • Lekarze Specjaliści Małolepszy i Partnerzy

    Wroclaw, 54239

  • ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy

    Wroclaw, PL-53-201

Other trials in Poland

Germany8 sites
  • Praxis fur Pneumologie am Duako

    Augsburg, Bavaria, 86150

  • Lungenpraxis Hohenzollerndamm RCMS

    Berlin, 10717

  • IKF Pneumologie Frankfurt GmbH & Co KG

    Frankfurt am Main, Hesse, 60596

  • KPPK Studienzentrum

    Koblenz, Rhineland-Palatinate, 56068

  • POIS Sachsen GmbH iG

    Leipzig, 04347

  • Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)

    Lübeck, Schleswig-Holstein, 23552

  • IKF Pneumologie GmbH & Co. KG

    Mainz, 55128

  • LMU University Hospital Munich

    Munich, Bavaria, 81377

Other trials in Germany

Canada7 sites
  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5

  • Institut Universitare de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval

    Québec, G1V 4G5

  • Clinique de Specialisee en Allergie de la Capitale

    Québec, G1V 4W2

  • Evidence Based Medical Educator Inc.

    Toronto, Ontario, M5G 1E2

  • Inspiration Research Limited

    Toronto, Ontario, M5T 3A9

  • The Lung Centre at Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Denmark1 site
  • Vejle Sygehus

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Puerto Rico1 site
  • PRCCI Clinical Research Center

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication.

The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA.

Read more

The study is also looking at:

  • What side effects may happen from taking dupilumab
Read the detailed description

This study is a Phase 3b in Canada Minors will not be enrolled in Denmark

Conditions
Asthma
Being tested
dupilumab, Matching Placebo, ICS/LABA
Keywords
Uncontrolled, Severe exacerbations, Type 2 Inflammation, Elevated blood eosinophils, Increased Fractional exhaled Nitric Oxide (FeNO), Atopy and elevated Immunoglobulin E (IgE)
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dupilumabDrug

    Also called Dupixent®, REGN668, SAR231893

    Administered by subcutaneous (SC) injection

  • Matching PlaceboDrug

    Administered by SC injection

  • ICS/LABADrug

    Also called fluticasone, propionate/salmeterol HFA, inhalation aerosol

    Administered at a blinded dose

Study groups in NCT06572228
Study groupRoleWhat they receive
Dupilumab + ICS/LABAExperimentalRandomized 1:1
Receives: Drug: dupilumab; Drug: ICS/LABA
Placebo + ICS/LABAPlacebo comparatorRandomized 1:1
Receives: Drug: Matching Placebo; Drug: ICS/LABA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized severe asthma exacerbation rate

    Measured: Baseline through Week 52

Secondary outcomes (14)
  1. Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1)

    Measured: Baseline to week 12

  2. Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations

    Measured: Baseline to week 52

  3. Change in Asthma Control Questionnaire (ACQ-5)

    The ACQ-5 has 5 items that assess the most common asthma symptoms: 1. Frequency in past week awoken by asthma during the night, 2. Severity of asthma symptoms in the morning, 3. Limitation of daily activities due to asthma, 4. Shortness of breath due to asthma and 5. Wheeze. Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The ACQ-5 global score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.

    Measured: Baseline to week 12

  4. Proportion of participants achieving ACQ-5 <1.5

    Measured: At week 12

  5. Change in pre-bronchodilator FEV1

    Measured: Baseline up to week 52

  6. Change in percent predicted FEV1

    Measured: Baseline up to week 52

  7. Change in peak expiratory flow (PEF)

    Measured: Baseline up to week 52

  8. Change in forced vital capacity (FVC)

    Measured: Baseline up to week 52

  9. Change in forced expiratory flow (FEF) 25-75%

    Measured: Baseline up to week 52

  10. Change in FEV1: FVC ratio

    Measured: Baseline up to week 52

  11. Change in post-bronchodilator FEV1

    Measured: Baseline up to week 52

  12. Time to first severe exacerbation event

    Measured: Up to week 52

  13. Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5

    Measured: Up to week 52

  14. Incidence of Treatment-emergent adverse event (TEAEs)

    Measured: Up to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start26 Aug 2024
  3. Primary completion24 Apr 2027 (estimated)
  4. Study completion24 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06572228
Sponsor's protocol ID
R668-AS-2373
Other IDs
2023-510458-18-00, 2023
Acronym
AIM4:Next Step
Status last verified
Apr 2026
First submitted
23 Aug 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dupilumab and ICS/LABA in people with Asthma, run by Regeneron Pharmaceuticals at 77 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Poland, Germany, Canada, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized severe asthma exacerbation rate (time frame: Baseline through Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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